Terminology used in the Life Sciences Space

This is a short list of the most commonly used abbreviations and terms used in Life Sciences. I will update this every now and then. If you have questions or comments or abbreviations not on the list, let me know!

Abbreviation

Meaning

Explanaition

Rx

Abbreviation for a prespription and in some contexts also for prescrition drugs

generic

A generic drug or “Generic” is a pharmaceutical product that is not protected by a patent anymore. Those products are typically sold via the name of the active ingredient (e.g. Acetylsalicylic Acid = A.S.S. rather than Aspirin) or generic name, thus the name.

OTC

Over-the-Counter

A drug that doesn’t require a prespription but is sold over the counter, so basically non-Rx.

Be careful not to confuse this with Order-to-Cash, abbreviated OTC as well or O2C. People might use the same abbreviation for both terms.

API

Active Pharmaceutical Ingredient

UDI

Unique Device Identifyer

used for medical devices

GMP

Good Manufacturing Practice

GLP

Good Laboratory Practice

GDP

Good Distribution Practice

GxP

summarizing GMP and GLP and all the other flavors

GAMP

Good Automated Manufacturing Practice

GAMP is a guide for the validation of automated systems in pharmaceutical Manufacturing and was issued by the UK Pharmaceutical Industry Computer Validation Forum. It is often used by companies to guide them through a validation project. see: www.ISPE.org

CFR

Code of Federal Regulation

US laws, covers for example GMP guidelines, e.g. the rule for electrionic records and signatures can be found in 21 CFR Part 11.

Part11

Part of the CFR covering digital and electronic signatures

NDC

National Drug Code

used for any national code used to identify pharmaceutical products, often used for the US NDC specifically

FDA

Food and Drug Administration

even though other countries also run an FDA, this typically relates to the US FDA

MoH

Ministry of Health

NDA

New Drug Application

the application you have to submit to register a new drug. Careful not to mix this up with a Non-Disclosure Agreement.

CANDA

Comuter Aided (or assisted) NDA

ANDA

abbreviated NDA

PDMA

Prescription Drug Marketing Act

CMO

Contract Manufacturing Organization

Company that manufactures a certain product on behalf of another company

MES

Manufacturing Execution System

A computer system used to manage the productio activitities (both manual and automated) on the plant floor

LIMS

Laboratory Information Management System

A computer system used to manage laboratory tasks (like chemical analysis for quality control), manages the resulting data and ultimately the batch characteristics.